Please click on the Apply to verify the status of jobs posted more than 15 days ago, as they may have expired. Similar Jobs
Job Description
Roles and responsibilities:
Strong understanding of EU MDR (2017/745), ISO 13485, ISO 14971.
Experience with device Sets and multi-supplier configurations.
Excellent documentation, review, and stakeholder communication skills.
Leading the MDR Team and Review
Review EU MDR Annex II/III Technical Documentation.
Ensure compliance with EU MDR 2017/745 for Class IIb devices.
Labeling & UDI
Author and verify labeling per ISO 15223-1 and ISO 20417.
Support UDI assignment and EUDAMED data entry.
Regulatory Compliance
Validate GSPR mapping, risk-benefit narratives, and CER references.
Maintain document version control and audit readiness.
Education qualification
Bachelors degree in Engineering, Biomedical, or related field.
Skills
Regulatory AffairsMdrMedical DevicesFDA13485Regulatory ComplianceRegulatoryMedicalIf a job posting appears fraudulent, asks for payment, contains misleading information, or violates our guidelines, please report it immediately. Our team will review it promptly, Jobaaj does not charge any fee from the applicants.
About Company
Important dates & deadlines?
Application Deadline
02 Mar 26, 04:42 PM IST
Similar Jobs
View All
Don't Miss out any Updates
Subscribe now for the latest job alerts
and never miss an update
